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Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy

4 Years
18 Years
Not Enrolling
Leukemia, Lymphocytic, Acute, L1

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Trial Information

Incidence of Osteoporosis in Children With Acute Lymphoblastic Leukemia Undergoing Therapy

Osteoporosis is a disease characterized by low bone mass and microarchitectural
deterioration of bone tissue. Osteoporosis is a devastating disorder with significant
physical, psychosocial and financial consequences. Intensive chemotherapy and radiotherapy
have led to significant improvements in long term, disease-free survival of children with
malignancies. Unfortunately, there are many deleterious side effects associated with this
therapy. Little is known about the longitudinal changes in bone mass accumulation and bone
metabolism in these patients.

The purpose of this study is to evaluate the timing and severity of changes in bone mineral
metabolism for children treated for childhood leukemia. Data will be used to establish
treatment protocols with the goal of preventing severe fractures and pain in the acute
treatment stage and severe osteoporosis and related pathology in the chronic stage.

Inclusion Criteria:

- All pediatric patients with a new diagnosis of ALL between ages 4-18

- Patients who are expected to receive glucocorticoids as part of the leukemia
treatment protocol

- Bone density measurements must be performed at the diagnosis visit or maximally
within 48 hours after the first dose of glucocorticoids

Exclusion Criteria:

- Patients under 4 years of age are excluded due to lack of age appropriate standards
for bone mineral density

- Glucocorticoid therapy of at least one month or longer within the six months prior to

- History of connective tissue or musculoskeletal disorders

- Biphosphonate therapy within the past 6 months

- Acute renal failure

- Serum creatinine equal to or higher than 4.5mg/dl

- Positive serum pregnancy test in adolescent females

Type of Study:


Study Design:

Observational Model: Defined Population, Observational Model: Natural History, Time Perspective: Longitudinal, Time Perspective: Prospective

Principal Investigator

Jadranka Popovic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Children's Mercy Hospital


United States: Institutional Review Board

Study ID:

03 08-085



Start Date:

March 2004

Completion Date:

October 2006

Related Keywords:

  • Leukemia, Lymphocytic, Acute, L1
  • Osteoporosis
  • Childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Osteoporosis



Children's Mercy Hospital Kansas City, Missouri  64108